Zobrazit v EDS

Oxaliplatin (3 months v 6 months) With 6 Months of Fluoropyrimidine as Adjuvant Therapy in Patients With Stage II/III Colon Cancer: KCSG CO09-07

Uloženo v:
Podrobná bibliografie
Název: Oxaliplatin (3 months v 6 months) With 6 Months of Fluoropyrimidine as Adjuvant Therapy in Patients With Stage II/III Colon Cancer: KCSG CO09-07
Autoři: Seung Tae Kim, Sun Young Kim, Jeeyun Lee, Seong Hyeon Yun, Hee Cheol Kim, Woo Yong Lee, Tae Won Kim, Yong Sang Hong, Seok-Byung Lim, Ji Yeon Baek, Jae Hwan Oh, Joong Bae Ahn, Sang Joon Shin, Sae-Won Han, Seong Geun Kim, Seok Yun Kang, Sun Jin Sym, Dae Young Zang, Yeul Hong Kim, In Sil Choi, Jung Hun Kang, Min-Ji Kim, Young Suk Park
Přispěvatelé: Seung Tae Kim, Sun Young Kim, Jeeyun Lee, Seong Hyeon Yun, Hee Cheol Kim, Woo Yong Lee, Tae Won Kim, Yong Sang Hong, Seok-Byung Lim, Ji Yeon Baek, Jae Hwan Oh, Joong Bae Ahn, Sang Joon Shin, Sae-Won Han, Seong Geun Kim, Seok Yun Kang, Sun Jin Sym, Dae Young Zang, Yeul Hong Kim, In Sil Choi, Jung Hun Kang, Min-Ji Kim, Young Suk Park, Shin, Sang Joon
Zdroj: J Clin Oncol
Informace o vydavateli: American Society of Clinical Oncology (ASCO), 2022.
Rok vydání: 2022
Témata: Organoplatinum Compounds, Leucovorin, Fluorouracil / therapeutic use, Colonic Neoplasms* / pathology, Disease-Free Survival, 03 medical and health sciences, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols / therapeutic use, Antineoplastic Combined Chemotherapy Protocols, Colonic Neoplasms* / drug therapy, Chemotherapy, Humans, Adjuvant, Capecitabine, Neoplasm Staging, Leucovorin / therapeutic use, Organoplatinum Compounds* / therapeutic use, ORIGINAL REPORTS, Oxaliplatin* / therapeutic use, 3. Good health, Oxaliplatin, Capecitabine / therapeutic use, Chemotherapy, Adjuvant, Colonic Neoplasms, Fluorouracil
Popis: PURPOSE The combination of oxaliplatin and fluoropyrimidine for 6 months is one of the standard options for adjuvant therapy for high-risk stage II and III colorectal cancers (CRCs). The optimal duration of oxaliplatin to diminish neurotoxicity without compromising efficacy needs to be clarified. PATIENTS AND METHODS This open-label, randomized, phase III, noninferiority trial randomly assigned patients with high-risk stage II and III CRC to 3 and 6 months of oxaliplatin with 6 months of fluoropyrimidine groups (3- and 6-month arms, respectively). The primary end point was disease-free survival (DFS), and the noninferiority margin was a hazard ratio (HR) of 1.25. RESULTS In total, 1,788 patients were randomly assigned to the 6-month (n = 895) and 3-month (n = 893) arms, and 83.6% in the 6-month arm and 85.7% in the 3-month arm completed the treatment. The neuropathy rates with any grade were higher in the 6-month arm than in the 3-month arm (69.5% v 58.3%; P < .0001). The 3-year DFS rates were 83.7% and 84.7% in the 6-month and 3-month arms, respectively, with an HR of 0.953 (95% CI, 0.769 to 1.180; test for noninferiority, P = .0065) within the noninferiority margin. Among patients with stage III CRC treated by capecitabine plus oxaliplatin, the 3-year DFS of the 3-month arm was noninferior as compared with that of the 6-month arm with an HR of 0.713 (95% CI, 0.530 to 0.959; P = .0009). However, among patients with high-risk stage II and stage III CRC treated by infusional fluorouracil, leucovorin, and oxaliplatin, the noninferiority of the 3-month arm compared with the 6-month arm was not proven. CONCLUSION This study suggests that adding 3 months of oxaliplatin to 6 months of capecitabine could be considered an alternative adjuvant treatment for stage III CRC (ClinicalTrials.gov identifier: NCT01092481 ).
Druh dokumentu: Article
Other literature type
Jazyk: English
ISSN: 1527-7755
0732-183X
DOI: 10.1200/jco.21.02962
Přístupová URL adresa: https://pubmed.ncbi.nlm.nih.gov/35772045
Rights: CC BY NC ND
URL: http://creativecommons.org/licenses/by-nc-nd/4.0/Creative Commons Attribution Non-Commercial No Derivatives 4.0 License: http://creativecommons.org/licenses/by-nc-nd/4.0/ (http://creativecommons.org/licenses/by-nc-nd/4.0/)
Přístupové číslo: edsair.doi.dedup.....69e80da50bed985f5cd7d01f57beefca
Databáze: OpenAIRE
Popis
Abstrakt:PURPOSE The combination of oxaliplatin and fluoropyrimidine for 6 months is one of the standard options for adjuvant therapy for high-risk stage II and III colorectal cancers (CRCs). The optimal duration of oxaliplatin to diminish neurotoxicity without compromising efficacy needs to be clarified. PATIENTS AND METHODS This open-label, randomized, phase III, noninferiority trial randomly assigned patients with high-risk stage II and III CRC to 3 and 6 months of oxaliplatin with 6 months of fluoropyrimidine groups (3- and 6-month arms, respectively). The primary end point was disease-free survival (DFS), and the noninferiority margin was a hazard ratio (HR) of 1.25. RESULTS In total, 1,788 patients were randomly assigned to the 6-month (n = 895) and 3-month (n = 893) arms, and 83.6% in the 6-month arm and 85.7% in the 3-month arm completed the treatment. The neuropathy rates with any grade were higher in the 6-month arm than in the 3-month arm (69.5% v 58.3%; P < .0001). The 3-year DFS rates were 83.7% and 84.7% in the 6-month and 3-month arms, respectively, with an HR of 0.953 (95% CI, 0.769 to 1.180; test for noninferiority, P = .0065) within the noninferiority margin. Among patients with stage III CRC treated by capecitabine plus oxaliplatin, the 3-year DFS of the 3-month arm was noninferior as compared with that of the 6-month arm with an HR of 0.713 (95% CI, 0.530 to 0.959; P = .0009). However, among patients with high-risk stage II and stage III CRC treated by infusional fluorouracil, leucovorin, and oxaliplatin, the noninferiority of the 3-month arm compared with the 6-month arm was not proven. CONCLUSION This study suggests that adding 3 months of oxaliplatin to 6 months of capecitabine could be considered an alternative adjuvant treatment for stage III CRC (ClinicalTrials.gov identifier: NCT01092481 ).
ISSN:15277755
0732183X
DOI:10.1200/jco.21.02962